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Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01970475
First Posted: October 28, 2013
Last Update Posted: December 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amgen
Results First Submitted: October 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Arthritis, Rheumatoid
Interventions: Biological: ABP 501
Biological: Adalimumab

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

This study was conducted at 92 centers in 12 countries in Europe, North America and Latin America.

The first participant enrolled on 24 October 2013 and the last participant enrolled on 26 May 2014.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were randomized 1:1 to receive either ABP 501 or adalimumab at 40 mg every 2 weeks for 22 weeks. Randomization was stratified by geographic region and prior biologic use for rheumatoid arthritis (capped at 40% of the study population).

Reporting Groups
  Description
ABP 501 Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
Adalimumab Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.

Participant Flow:   Overall Study
    ABP 501   Adalimumab
STARTED   264   262 
COMPLETED   243   251 
NOT COMPLETED   21   11 
Withdrawal by Subject                11                6 
Adverse Event                7                3 
Lost to Follow-up                2                2 
Protocol Violation                1                0 



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 24   [ Time Frame: Baseline and Week 24 ]

2.  Secondary:   Change From Baseline in Disease Activity Score 28-C-reactive Protein (DAS28-CRP)   [ Time Frame: Baseline and weeks 2, 4, 8, 12, 18, and 24 ]

3.  Secondary:   Percentage of Participants With an ACR20 Response at Week 2 and Week 8   [ Time Frame: Baseline, week 2 and week 8 ]

4.  Secondary:   Percentage of Participants With an ACR50 Response at Week 24   [ Time Frame: Baseline and week 24 ]

5.  Secondary:   Percentage of Participants With an ACR70 Response at Week 24   [ Time Frame: Baseline and Week 24 ]

6.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: From the time of first treatment up to 28 days following the last dose of study treatment; 26 weeks. ]

7.  Secondary:   Percentage of Participants Who Developed Antibodies to ABP 501 or Adalimumab   [ Time Frame: Up to week 26 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Amgen Inc.
phone: 866-572-6436



Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01970475     History of Changes
Other Study ID Numbers: 20120262
2013-000525-31 ( EudraCT Number )
First Submitted: October 23, 2013
First Posted: October 28, 2013
Results First Submitted: October 20, 2016
Results First Posted: December 13, 2016
Last Update Posted: December 13, 2016